Valtonen S, Timonen U, Toivanen P, Kalimo H, Kivipelto L, Heiskanen O, Unsgaard G, Kuurne T
Department of Neurosurgery, Turku University Central Hospital, Finland.
Neurosurgery. 1997 Jul;41(1):44-8; discussion 48-9. doi: 10.1097/00006123-199707000-00011.
To find out the effect of carmustine (bischloroethyl-nitrosourea) combined with a biodegradable polymer in the treatment of malignant (Grades III and IV) gliomas, applied locally, at the time of the primary operation.
Prospective, randomized double-blind study of an active treatment group versus a placebo group. Conducted at the Departments of Neurosurgery of the University Hospitals of Helsinki, Tampere, and Turku in Finland and Trondheim in Norway. The study consisted of 32 patients (16 in each treatment group) enrolled between March 23, 1992, and March 19, 1993. The study was planned to include 100 patients but had to be terminated prematurely, because the drug that was being used had become unobtainable. The main outcome measures included the survival times of patients after the operations and the application of an active drug or placebo.
The median time from surgery to death was 58.1 weeks for the active treatment group versus 39.9 weeks for the placebo group (P = 0.012). For 27 patients with Grade IV tumors, the corresponding times were 39.9 weeks for the placebo group and 53.3 weeks for the active treatment group (P = 0.008). At the end of the study, six patients were still alive, five of whom belonged to the active treatment group.
Carmustine applied locally in a biodegradable polymer at the time of primary operation, seems to have a favorable effect on the life span of patients with high-grade gliomas.
研究卡莫司汀（双氯乙基亚硝脲）与一种可生物降解聚合物联合，在初次手术时局部应用于治疗恶性（III级和IV级）胶质瘤的效果。
对一个活性治疗组和一个安慰剂组进行前瞻性、随机双盲研究。研究在芬兰赫尔辛基、坦佩雷和图尔库大学医院以及挪威特隆赫姆的神经外科进行。该研究纳入了1992年3月23日至1993年3月19日期间的32例患者（每个治疗组16例）。该研究原计划纳入100例患者，但因所用药物无法获得而不得不提前终止。主要观察指标包括手术后及应用活性药物或安慰剂后患者的生存时间。
活性治疗组从手术到死亡的中位时间为58.1周，而安慰剂组为39.9周（P = 0.012）。对于27例IV级肿瘤患者，安慰剂组和活性治疗组的相应时间分别为39.9周和53.3周（P = 0.008）。研究结束时，有6例患者仍存活，其中5例属于活性治疗组。
在初次手术时将卡莫司汀局部应用于可生物降解聚合物中，似乎对高级别胶质瘤患者的寿命有积极影响。
